FEATURED EDITORIAL
Chief Editor Louis Garguilo says like many readers, he agrees with the "wise and narrow decision" by the U.S. Supreme Court that President Trump cannot use the International Emergency Economic Powers Act to impose sweeping tariffs. At the same time, for those who immediately threw up an instant “Hooray!” he suggests checking yourself on why such enthusiasm. His analysis on what is actually best for our global outsourcing industry.
- The Hidden Engineering Behind Successful Upstream Bioprocessing
- A Practical Look At Modern Downstream Processing For Biologics
- From Biology Grad To Manufacturing Guru
- Process Engineering's Key Role In Sterile Injectable Facility Design
- What To Know About — And How To Apply For — FDA's PreCheck Pilot
- MES Is Still In The CD ROM Era But The Data Architecture Has Moved On
- A Novel In Vitro Glycosylation Approach For Difficult PTMs
GUEST COLUMNISTS
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A Practical Look At Modern Downstream Processing For Biologics
Part 2 in a series about current bioprocessing practices explores the latest in separation, purification, sterile filtration and aseptic filling.
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Process Engineering's Key Role In Sterile Injectable Facility Design
Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.
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What To Know About — And How To Apply For — FDA's PreCheck Pilot
FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.
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MES Is Still In The CD ROM Era But The Data Architecture Has Moved On
Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.
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A Novel In Vitro Glycosylation Approach For Difficult PTMs
Post-translational modifications of membrane proteins have been historically challenging. Research shows how an in vitro approach brings stability and predictability.
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Field Notes: Reducing Risk At Kivi Bio's Interchangeability Conference
Risk and fitness for use of interchangeable single-use parts were key themes at the conference. The event exposed communication gaps between suppliers and end-users.
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Using Carbon Nanotubes To Pinpoint Optimal Harvest Time in Bioprocessing
Cell-free expression systems confound the moment of peak expression. These nanosensors signal through crude lysate for process optimization and endpoint monitoring.
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U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact
Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.
PHARMA OUTSOURCING WHITE PAPERS
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Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy
The most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.
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Accelerating ADC Clinical Development Timelines
For ADC developers, obtaining the desired payload can be a challenge, as their synthesis is more complex than most other small molecules. Learn about a more efficient approach to payload synthesis.
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Developing Pulmonary Dosage Forms For Complex Molecule Delivery
Discover how next-generation inhalation technologies can transform pulmonary drug delivery and unlock new therapeutic possibilities for a wide range of respiratory diseases.
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Mitigating Nitrosamine Risks In Pharmaceuticals
Nitrosamines can come from a range of sources, including raw materials, manufacturing processes, and even water sources. Detecting them requires sensitive analytical methods.
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Handle Single-Use Technology Biopharma Waste: Data Sharing, Collaboration
Learn more about data sharing and collaboration to enable a better environmental impact of single-use technologies (SUTs) and quantifying the single-use plastic waste generated when manufacturing mAbs.
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Next-Generation CRISPR Approaches
By providing essential components like nucleases, gRNAs, and HDR templates, a reliable CDMO facilitates a seamless transition from discovery research to clinical trials and beyond.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- Performance Of Mobius® Bag Assemblies With Ultimus® Film In Truck Shipping Simulation Test
- Providing Packing And Blinding Solutions For An Innovative Drug Start-Up
- Covalent Warhead Reactivity: A New Look At GSH Reactivity Assays
- Smart Scale-Up: Expanding Viral Vectors With Microcarrier Bead Technology
- Engineering The Future Of Lipsomal Drug Delivery
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ON-DEMAND WEBINARS
- Integrated Thinking for Complex FIH Programs
- Revolutionizing Gene Therapy Manufacturing: Robotics, ML For Process Intensification
- Using Rapid Development Framework™ To Accelerate CGT Development, Manufacturing
- From Concept To Market: Scaling And Manufacturing Semi-Solid Topical Drugs
- Beyond Solid Phase Synthesis